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FDA 510(k)

TIPCAM1 Rubina Video Endoscope System

K-Number: K201526 · 2020-11-20

ApplicantKarl Storz Endoscopy America
Decision Date2020-11-20
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TIPCAM1 Rubina Video Endoscope System is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz Endoscopy America. It received FDA 510(k) clearance on 2020-11-20 under 510(k) number K201526. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TIPCAM1 Rubina Video Endoscope System?

TIPCAM1 Rubina Video Endoscope System is a medical device that received FDA 510(k) clearance on 2020-11-20. The listed applicant is Karl Storz Endoscopy America. The 510(k) number is K201526.

When did TIPCAM1 Rubina Video Endoscope System receive FDA 510(k) clearance?

TIPCAM1 Rubina Video Endoscope System received FDA 510(k) clearance on 2020-11-20, under 510(k) number K201526.

Who is the listed applicant for TIPCAM1 Rubina Video Endoscope System?

The FDA 510(k) record lists Karl Storz Endoscopy America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TIPCAM1 Rubina Video Endoscope System?

The FDA product code for TIPCAM1 Rubina Video Endoscope System is GCJ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Other records listing Karl Storz Endoscopy America as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212458Flexible Video-Uretero-Renoscope SSU SystemK212656Flexible Intubation Video Endoscope – Sterile (FIVE-S)K212695KARL STORZ ICG Imaging SystemK201001Modulith SLX-F2

Related Devices (Code: GCJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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